Shelf life
-based on time required for the drug content to decrease to 90% of the label claim (t90 ) at the recommended storage temperature.
Expiration date
-the date placed on the container label of a drug product designating the time prior to which a batch of the product is expected to remain within the approved shelf life specification if stored under defined conditions, and after which it must not be used.
shelf life (expiration dating period)
-the time period during which a drug product is expected to remain within the approved shelf-life specification, provided that it is stored under the conditions defined on the container label
hydrolysis, oxidation, photolysis, thermal degradation, racemization
List some mechanisms of degradation?
rate law
The order of a chemical reaction is determined by ______
zero order
A ______ reaction is one in which the rate is independent on the concentrations of the reactants.
half-life
The _______ of a zero order reaction is dependent on initial concentration.
a
Fraction of drug lost changes over time.
a. zero order
b. first order
c. third order
a, c
Amount of drug lost over time is constant .
a. zero order
b. first order
c. second order
zero order
what reaction is this graph depicting?
first-order
A _____ reaction is one where the rate of reaction is directly proportional to the concentration of one of the reactants
first order
this unit applies to what reaction, time-1
zero order
concentration/time applies to what reaction?
first order
this graph applies to what reaction?
b
Amount lost over time is changing.
a. zero order
b. first order
c. second order
b
Fraction of drug lost over time is a constant.
a. zero order
b. first order
c. second order
b
Half life is independent of concentration and is thus a constant over time.
a. zero order
b. first order
c. second order
pseudo-first order; concentration of A doesn't change much
If the initial concentration of reactant A is much larger than concentration B, what type of reaction is this and why does this occur?
c
Drug loss over time remains constant as long as the reservoir has enough drug remaining.
a. pseudo- first order
b. second order
c. pseudo-zero order
pseudo zero order
The reaction kinetics are first order process but it mimics a zero order rate of drug loss
returns to 1st order
In regards to Pseudo-zero order, after all drug in reservoir is consumed, the reaction _____
second order
-reaction rate depends on the concentration of two reactants